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Rashi at 630-847-1027

Position will be responsible for developing and executing verification and validation protocols related to Renal therapy. Experience in translating product requirements into test / use cases, essential. The position will be responsible for a portion of a fluid handling system. Responsibilities include design and development of precision plastic devices and components, developing test plans for functional testing, biocompatibility testing of materials and qualification of sterile packaging.

As the primary job function of this position is in the design arena, the Engineer will manage /update the Design History File (DHF), direct experimental design, author protocol development and technical reports when needed.

This position will report progress weekly to a management team and will require excellent communication skills to work globally and cross functionally. In this role the engineer will manage routine small projects without assistance, recommending design improvements as needed.

These responsibilities include:
Technical writing, solid modeling, statistical analysis, cross functional communication, experimental design, and verification and validation of requirements and user needs.
Experience working in a Design Control governed environment is desirable.
Knowledge should include experience with device Design History File structure, Risk Management documentation and Product Requirements management, statistics and Test Method Validation.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of "Six Sigma" quality techniques.
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
4) BS in Mechanical/ Biomedical/ Chemical Engineering.
5) 2-5 years Medical Device experience.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.